Status:
COMPLETED
Treatment With Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Prostate Cancer
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out how effective 177Lu -J591 is in the treatment of patients with metastatic, androgen-independent prostate cancer.
Detailed Description
To determine the clinical activity of 177Lu -J591 for the treatment of patients with metastatic, androgen-independent prostate cancer. Patients will receive a single dose of J591 (total antibody of 2...
Eligibility Criteria
Inclusion
- Histologic diagnosis of prostate adenocarcinoma.
- Metastatic prostate cancer progressive on imaging studies and/or rising PSA despite adequate medical or surgical castration therapy.
- Progressed following discontinuation of anti-androgen therapy, if received.
- Serum testosterone \< 50 ng/ml
Exclusion
- Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of treatment.
- Use of PC-SPES within 4 weeks of treatment.
- Use of red blood cell or platelet transfusions within 4 weeks of treatment.
- Use of hematopoietic growth factors within 4 weeks of treatment.
- Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.
- Bone scan demonstrating confluent lesions involving both axial and appendicular skeleton.
- Prior radiation therapy encompassing \>25% of skeleton.
- Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®).
- Active angina pectoris or NY Heart Association Class III-IV.
- History of deep vein thrombophlebitis and/or pulmonary embolus within 3 months of study entry.
- Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
- Prior monoclonal antibody therapy with the exception of ProstaScint®
- Prior investigational therapy (medications or devices) within 6 weeks of treatment.
- Known history of HIV
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00195039
Start Date
August 1 2004
End Date
October 1 2013
Last Update
October 5 2017
Active Locations (1)
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1
Weill Medcial College of Cornell University
New York, New York, United States, 10065